Identity
- Trade Name
- HDL Cholesterol EUDAMEDCholesterol EUDAMEDAU FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- HDL Cholesterol EUDAMEDCholesterol EUDAMEDFDA UDI
- Model / Reference
- OSR6687 EUDAMEDOSR6616 EUDAMEDFDA UDI
- Description
- Cholesterol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590060220 EUDAMED15099590060060 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902OSR6687P5 EUDAMED150995901OSR6616MT EUDAMED
- FDA Product Code
- CHH FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HDL Cholesterol by Beckman Coulter Ireland Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902OSR6687P5 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (3)
- EUDAMED d5be50ed-88a1-4c5e-a108-39cb9a0ed895 61 fields · synced Oct 6, 2026
- FDA UDI a3560f4b-0501-4d49-9d16-5ef383841ba4 33 fields · synced May 29, 2026
- EUDAMED ad0ecbf4-7551-43b4-a701-a54f98d95867 61 fields · synced Jul 9, 2026